Shapeable intraluminal device and method therefor

ABSTRACT

A hollow medical device includes a coil member having a distal end, a proximal end, a plurality of turns extending therebetween, and a lumen extending through the turns. The coil member further includes at least one weld extending from one turn to an adjacent turn.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 10/249,453 filed Apr. 10, 2003 now U.S. Pat.No. 7,303,533

BACKGROUND OF THE INVENTION

This invention relates generally to intraluminal devices used in medicalinterventional procedures, and in particular to vascular interventions.

Intraluminal devices, e.g., guide wires, are steered through bodypassages such as arteries or veins by shaping the wire and thenmanipulating the proximal end of the wire while pushing the wire throughthe passage. Often, the wires are manipulated under x-ray visualization.By rotating the proximal end of the wire, the shape formed in the distalend changes orientation allowing the operator to select directions,especially where the vessel divides into multiple paths.

Being able to shape the guide wire, especially its distal end, isimportant to the effectiveness of the particular guide wire as anintervention tool. Operators have a strong preference to form their ownshape in the wire, often customizing the wire to the specific anatomythrough which the guide wire is being navigated.

Guide wires are described extensively in the art. Most of the guidewires are designed around a central core element with a wire or ribbonof material wrapped around the central core. The core imparts many ofthe mechanical properties of the wire and is generally responsible forallowing the guide wire to be shaped. These guide wires are typicallyshaped by imparting plastic deformation to the core which retains thisdeformation during use of the guide wire.

For most interventional procedures the guide wire acts as a rail toallow other devices, such as angioplasty balloons and stents, to beplaced precisely in a vessel. However, guide wires themselves haveevolved to be therapeutic devices. For example, balloons or wire mesheshave been placed within the guide wire structure to become distalembolic protection devices during interventions. Guide wires also havebeen used to conduct radio frequency energy to ablate tissue.

Often, the central core of the guide wire has to be removed oreliminated to allow other functional elements to be added to the wirewhile minimizing the profile of the guide wire so it can be advancedinto smaller body vessels. Such guide wires include, but are not limitedto, infusion guide wires capable of delivering drugs or therapeuticmaterials such as embolic agents; guide wires with removable centralcores; hollow core wires for pressure measurements; and guide wires thathave optical fibers to visualize or deliver light energy.

BRIEF DESCRIPTION OF THE INVENTION

In accordance with one aspect of the invention, a hollow medical deviceis provided that comprises a coil member. The coil member comprises adistal end, a proximal end, a plurality of turns extending therebetween,and a lumen extending through said turns. The coil member furthercomprising at least one weld extending from one turn to an adjacentturn.

In another aspect of the invention, a method is provided for shaping anintraluminal device having a coiled member. The method comprisingforming the coil member including a distal end, a proximal end, aplurality of turns extending between the proximal end and the distalend, and a lumen extending through the turns, connecting at least oneturn of the coil member to an adjacent turn, and bending the coil memberat the connected turns into a shape suitable to traverse a body lumen.

In a further aspect of the invention, a medical device is provided forinsertion into a body lumen. The medical device comprising a coilcomprising a plurality of turns, a lumen extending through the turns,and at least one weld extending from a first turn to an adjacent turn.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a portion of a conventional guide wire that includesa central core element and a wire wound coil that forms the outerportion of the guide wire.

FIG. 2 illustrates a shapeable coil in accordance with one embodiment ofthe invention.

FIG. 3 illustrates a portion of a guide wire including an optical fibermember surrounded by a wire wound coil.

FIG. 4 illustrates a portion of a guide wire including a tube utilizedto inflate a balloon at a distal end of the guide wire.

FIG. 5 illustrates a guide wire including a tube utilized to deliverdrugs or reagents to a distal tip of, or to some intermediate pointalong the length of, the guide wire.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary embodiments of shapeable intraluminal devices and methods ofproviding and using shapeable intraluminal devices are described below.In one embodiment, the shapeable device is a guide wire having ashapeable tip formed from a coil with adjacent turns fastened togetherand a lumen extending through the turns of the coil. The shapeable tipmaintains its shape due, at least in part, to the attachment of adjacentcoils. The lumen allows passage of fluids, e.g., drugs or reagents,therethrough. In an alternative embodiment, the shapeable tip includescomponents such as optic fibers, tubes, balloons, and wire meshes. Theshapeable tip can be shaped to allow the operator to steer the wire byconventional rotating techniques from outside the patient's body.

Although exemplary embodiments are described herein, the intraluminaldevices and methods are not limited to those specific embodiments. Forexample, although an exemplary embodiment of a guide wire is describedbelow in detail, it is to be understood that the shapeable coil of thepresent invention is applicable to catheters as well as other medicaldevice utilizing a coil that is to retain a bent or curvedconfiguration. As another example, although the present invention isdescribed in the context of a shapeable tip, it is to be understood thatthe shapeable coil, or portion of the coil, can be positioned at anylocation along the length of the medical device. As a further example,although the method of attaching adjacent turns of the coil is describedas welding, it is to be understood that attachment methods such asbrazing and soldering are also applicable to the present invention.

The intraluminal devices and methods are illustrated with reference tothe figures wherein similar numbers indicate the same elements in allfigures. Such figures are intended to be illustrative rather thanlimiting and are included herewith to facilitate explanation of anexemplary embodiment of the devices and methods of the invention.

Guide wires are generally constructed from many materials. Specifically,the central core and coils of known guide wires are typicallymanufactured from metallic and non-metallic wires or ribbons, e.g.,stainless steel, Nitinol, and polymers. Stainless steels are utilizeddue to their ductility, corrosion resistance, and ability to be easilysterilized. Nitinol, a nickel-titanium alloy, is useful for its uniquesuperelastic and shape memory properties. In addition, coils can also befabricated from heavy metals such as platinum, platinum-iridium, andgold for radiopacity. Graphite non-metallic fibers have also been usedin composite materials. Coils are commercially available from manysources or can be custom wound. Such coils can be wound from singlestrands or can be cable-like with multiple filars. One important aspectof guide wires, as well as other intraluminal medical devices, is thatthey have a low profile. For guide wires, profiles less than 0.038inches outer diameter are typically desirable and profiles as low as0.010 inches outer diameter are sometimes desirable.

FIG. 1 illustrates a portion of a conventional guide wire 10 thatincludes a central core element 12 and a wire wound coil 14 that formsthe outer portion of guide wire 10. Central core element 12 helps totransmit torque from a first end 16 of the wire to a second end 18 andis responsible for many of the mechanical properties of guide wire 10such as stiffness and rigidity. Central core element 12 also allows ashape to be imparted to, and retained by, wire 10 by bending coreelement 12 plastically so that an angle or curve is retained in guidewire 10. Wound coil 14 provides flexibility to guide wire 10 fornavigating tortuous paths while being able to transmit rotationalmovement in a smooth transition from first end 16 to second end 18.

FIG. 2 illustrates a shapeable coil 20 in accordance with one embodimentof the invention. Coil 20 includes a lumen (not shown) extending throughan interior of coil 20 and a plurality of welds 22 connecting adjacentturns 24 of coil 20. Since coil 20 does not include a central core, ashape retention member is incorporated into coil 20. Coil 20 isfabricated to perform as a shape retention member by the joining ofadjacent turns 24. This joining of adjacent turns 24 creates astructural member that is stiffer than a coil without joined adjacentturns and that can be plastically deformed. For metal coils, thisfabrication is performed by precision welding techniques includinglaser, electron beam, pulse-arc, and parallel gap resistance welding. Inan alternative embodiment, the joining of adjacent turns 24 of coil 20utilizes brazing or soldering techniques. As a further alternative, formetallic and non-metallic coils, this fabrication utilizes applicationsof adhesives including glues, epoxies, and metal-filled epoxies.

Welding adjacent turns 24 of coil 20 allows a ductile member to beformed from a portion of coil 20. The heat-affected zone around welds 22essentially anneals turns 24 allowing them to remain flexible. Weldedcoil 20 is plastically deformable by an operator to a desired shape andalthough there may be some recoil (elastic deformation) of the deformedcoil, this recoil can be corrected by over shaping the component tocompensate for the recoil.

The degree of stiffness of coil 20 and a guide wire into which coil 20is located can be controlled by the depth and/or thickness of weld 22 aswell as the number of welds 22. In one embodiment, the weld extendsbetween two adjacent turns. In an alternative embodiment, the weldextends between at least three adjacent turns. In an exemplaryembodiment, weld 22 is perpendicular to an axis 26 of coil 20 thatextends from a first end 28 of coil 20 to a second end 30 of coil 20. Inalternative embodiments, welds 22 are formed in parallel to each otherand/or in intersecting patterns in the area that is intended to beshaped or made stiffer. In addition, welds 22 can be continuous or spotwelds.

FIG. 3 illustrates a portion of a guide wire 40 including an opticalfiber member 42 surrounded by a wire wound coil 44. In one embodiment,optical fiber member 42 is a single optical fiber. In an alternativeembodiment, optical fiber member 42 is a bundle of optical fibers. Guidewire 40 also includes a tube 46 connected to a proximal end of coil 44.Coil 44 includes a plurality of turns 48 and a weld 50 connectingadjacent turns.

FIG. 4 illustrates a portion of a guide wire 60 including a tube 62utilized to inflate a balloon 64 at a distal end 66 of guide wire 60.Guide wire 60 also includes a coil 68 including a pair of welds 70joining adjacent turns 72. Coil 68 is illustrated in a bentconfiguration. As illustrated, the bent shape imparted to coil 68 ismaintained by plastic deformation of welds 70. Guide wire 60 isutilized, in one embodiment, for occluding a vessel to trap materialduring a therapy, e.g., block an artery to protect against distalembolization during an angioplasty.

FIG. 5 illustrates a guide wire 80 including a tube 82 utilized todeliver drugs or reagents 84 to a distal tip 86 of, or to anintermediate point along the length of, guide wire 80. Guide wire 80also includes a coil 88 including a plurality of welds 90 formed in apattern that connect adjacent turns 92. Guide wire 80, in oneembodiment, is a perfusion device.

A method of forming coils 20, 44, 68, and 88 includes manufacturing astraight wire or ribbon. The wire or ribbon is then wound around amandrel to form a coil. Welds, such as welds 22, 50, 70, and 90 areapplied to the coil in the areas likely to require shaping to accomplishthe intended use of the device. In one embodiment, the welds are locatedat the distal end of the coil. In alternative embodiments, the welds arelocated at other positions along the coil. The interventional operatorthen forms a shape into the wire in the area of the welds. In oneembodiment, the shaping is imparted by pinching the coil between theoperator's fingers. Alternatively, the shaping is imparted by rollingthe coil across the sides of curved instrument, e.g., forceps or a rod.In a further alternative embodiment, the coil is shaped according toother methods. Although the coil is typically shaped prior to entry ofthe coil into a body, the coil can be shaped by a user at any timeduring a procedure simply by removing the device from the body andreshaping the coil to accommodate the anatomy.

While the invention has been described in terms of various specificembodiments, those skilled in the art will recognize that the inventioncan be practiced with modification within the spirit and scope of theclaims.

1. A hollow medical device comprising a coil member comprising a distalend, a proximal end, a plurality of turns extending therebetween, and alumen extending through said turns, said coil member comprising aplurality of intersecting welds extending from one turn to an adjacentturn to provide stiffness to said coil, and plurality ofnon-intersecting welds extending from one turn to an adjacent turn tofrom at least one ductile member, said coil member configured to beplastically deformed by bending said ductile member at the plurality ofnon-intersecting welds, such that said ductile member retains a bentshape of said coil member, said lumen configured to house at least oneof an optical fiber, a balloon inflation tube, a drug delivery tube, anda reagent delivery tube.
 2. A hollow medical device in accordance withclaim 1 wherein said device comprises one of a catheter and a guidewire.
 3. A hollow medical device in accordance with claim 1 wherein saidcoil member comprises at least one of a helical coil of wire and a woundribbon.
 4. A hollow medical device in accordance with claim 1 whereinsaid coil member comprises metal.
 5. A hollow medical device inaccordance with claim 4 wherein said metal is at least one of steel andnitinol.
 6. A hollow medical device in accordance with claim 1 whereinsaid coil member includes an axis extending from said proximal end tosaid distal end, said plurality of non-intersecting welds substantiallyparallel to said axis.
 7. A hollow medical device in accordance withclaim 1 wherein at least one of said plurality of non-intersecting weldsconnects at least three adjacent turns.
 8. A hollow medical device inaccordance with claim 1 wherein said device further comprises a distaltip, said distal end connected to said distal tip.
 9. A method forshaping an intraluminal device having a coiled member configured tohouse at least one of an optical fiber, a balloon inflation tube, a drugdelivery tube, and a reagent delivery tube, said method comprising:forming the coil member including a distal end, a proximal end, aplurality of turns extending between the proximal end and the distalend, and a lumen extending though the turns; welding a plurality ofintersecting welds that extend from one turn to an adjacent turn toprovide stiffness to said coil; welding a plurality of non-intersectingwelds that extend from one turn to an adjacent turn to form a ductilemember; and plastically bending the ductile member at the plurality ofnon-intersecting welds into a bent shape suitable to traverse a bodylumen, such that the ductile member retains the bent shape of the coilmember.
 10. A method in accordance with claim 9 wherein plasticallybending the coil member comprises plastically deforming the coil memberat the plurality of non-intersecting welds.
 11. A method in accordancewith claim 9 wherein welding comprises at least one of welding andsoldering the at least one turn of the coil member to an adjacent turn.12. A method in accordance with claim 9 further comprising welding atleast three adjacent turns.
 13. A medical device for insertion into abody lumen, said medical device comprising a coil comprising a pluralityof turns, a plurality of intersecting welds that extend from one turn toan adjacent turn to provide stiffness to said coil, a plurality ofnon-intersecting welds that extend from one turn to an adjacent turn toform a ductile member, and a lumen extending through said turns, saidlumen configured to house at least one of an optical fiber, a ballooninflation tube, a drug delivery tube, and a reagent delivery tube, saidcoil configured to be plastically deformed by bending said coil at saidductile member, such that said ductile member retains a bent shape ofsaid coil member.
 14. A medical device in accordance with claim 13wherein said device comprises one of a catheter and a guide wire.
 15. Amedical device in accordance with claim 13 wherein said coil comprisesat least one of a helical coil of wire and a wound ribbon.
 16. A medicaldevice in accordance with claim 13 wherein said coil comprises is atleast one of steel and nitinol.
 17. A medical device in accordance withclaim 13 wherein said plurality of non-intersecting welds aresubstantially parallel to said turns.
 18. A medical device in accordancewith claim 13 wherein at least one of said plurality of non-intersectingwelds connects at least three adjacent turns.
 19. A medical device inaccordance with claim 13 wherein a portion of said turns are annealedand flexible, said coil having a hollow body.
 20. A medical device inaccordance with claim 13 wherein a portion of said turns are annealedand flexible.